General Electric Legal & Compliance Counsel PDx, Japan APAC Region in Minato, Japan
Job Description Summary
Lawyers and non-lawyers providing leadership and oversight to business operations to assure adherence to all aspects of internal company and external regulatory compliance. Insures appropriate mechanisms are in place to comply with relevant laws and regulations, and adherence to corporate programs and practices. Interprets simple internal and external business challenges and recommends best practices to improve products, processes or services. Stays informed of industry trends that may influence work.
Description: PDx Legal & Compliance Counsel JAPAN/APAC
The Counsel for Japan and APAC (excl. China) , (the Region ) will have responsibility for providing legal advice on all aspects of the company’s operations and initiatives in the Region with predominant focus on Japan, as well as structuring and negotiating a variety of strategic commercial contracts with GE’s key customers throughout the Region, with a focus on GE Healthcare ’s Pharmaceutical Diagnostics business (the PDx Business ). These transactions and contracts typically include a wide range of products, software, and service offerings. Acting as a business partner, the Counsel is expected to provide advice to the senior business leaders on observed opportunities and direction, as well as to advise team members on day to day legal issues. The position will report directly to PDx General Counsel and will coordinate closely with PDx Chief Compliance Counsel and the Global and Regional legal and compliance teams. Though the Counsel will work primarily on matters related to Japan , he or she will need to be flexible and ready to work on matters relating to other APAC countries with the exclusion of China. . The role will benefit from being part of the GE Healthcare Global Law & Policy Team, a large worldwide network of lawyers, compliance professionals, and other legal support roles.
Key responsibilities/essential functions include:
Working with the Business’ Commercial team for the Region as a business partner to help identify opportunities to drive business forward and support growth opportunities and initiatives.
The Legal Counsel will coordinate with all functions through the development of winning strategies on PDx contractual agreements, identify and mitigate risks in new agreements; Ensuring contractual rigor; drafting, reviewing and negotiating strategic and commercial business agreements and transactions with PDx key strategic customers (e.g. GPOs, wholesalers, contractors etc..);Providing legal and compliance training for the broader region teams, particularly on contract terms and conditions; Providing regulatory and compliance advice in conjunction with the Regulatory and Compliance specialist areas in PDx, in relation to Pharma compliance and Pharma regulatory matters; Foreign Corrupt Practices Act (FCPA), , anti-corruption local (and other global as applicable) laws and industry regulations guidance documents will be a core focus of this role, along with the transactional/contract activities.
Compliance Program: The legal and compliance counsel will establish and maintain a legal-compliance infrastructure aligned with local laws, industry standards, and company policy. Prevent, detect and correct compliance gaps. Implement GEHC/PDx Compliance policy/procedures;
Develop innovative & effective messaging to employees around our ethics & integrity culture. Work with local leaders to create an education plan that delivers high-priority, industry-specific content to prevent compliance concerns. Train teams on policy, laws & codes
Work with legal and compliance colleagues to provide guidance to deal teams on fraud & abuse, regulatory, privacy antitrust and advertising/promotional legal issues.
Supporting the development and maintenance of a strong culture of compliance including supporting Compliance projects, including support to the Compliance Review Board.
Managing outside counsel, when brought in to assist.
In conjunction with the other business counsels, managing / supporting the management of disputes and litigation.
Applying combined business and legal judgment to proposed deals, relationships and other issues requiring legal or compliance attention.
Conducting impactful trainings to the Business’ team in relation to legal, regulatory and compliance matters.
Assisting on matters of corporate housekeeping such as related to powers of attorney, shareholders meetings and shareholding structures.
Help manage relationships with government authorities as and when needed e.g. in relation to corporate and business licenses, Pharmaceutical authorities, Ministries of Health, in close partnership with our government affairs team.
Collaborate, as needed, with global product and business development, marketing and medical services teams on executing worldwide PDx initiatives impacting the Region
Provide specialist advice on matters of local law across the Region, in particular on public procurement laws, competition laws and integrity laws (anti-bribery and anti-corruption), anti-money laundering and anti-terrorist financing laws.
Drafting and Reviewing Sales & Supply agreements, Clinical Development and Clinical research agreements, Contract Manufacturing Agreements, Co-development and licensing agreements, Advertising and Promotional Reviews, service contracts in accordance with the Business’ policies and procedures.
Support, as and when applicable, the Business and the Region in relation to internal audits, external audits and follow up items resulting from such audits.
Support PDx’s specialist on the screening and on-boarding of third-party vendors / suppliers / partners, including by way of conducting on-boarding interviews.
Advising on matters of intellectual property, as and when applicable.
Supporting the Business on all aspects of distributor relationships with distributors and wholesalers across the Region, including the (yearly or bi-yearly) renewal of distribution and/or wholesalers agreements, the delivery of legal and compliance training to the management and employees of the Business’ distributors and wholesalers; the management of issues with and the termination of distributors and/or wholesalers;
Collaborate, interact and leverage regional counsels within the GE Healthcare Global Law & Policy Team in particular with reference to the APAC (excl. China) sub-region,
Participate and contribute in global projects as needed
Required Qualifications: (outline the minimum requirements)
Excellent verbal and written communication in English and Japanese mother tongue . JD (or equivalent) with active bar membership in Japan. Bar admission in other countries a plus Minimum 8-10 years of relevant legal, compliance, regulatory experience, with at least 4 years in a law firm or a multinational company’s corporate legal department working on a variety of Healthcare/Pharma business legal matters in the Region, including previous experience of drafting, negotiating and closing business transactions . Experience of the Pharmaceutical industry and previous exposure to Healthcare and Pharma industry regulations in Japan. Experience and knowledge of the typical Pharmaceutical/Life Sciences/Healthcare compliance risks, knowledge of the local (Japan) compliance laws, rules and industry regulations and ability to advise the business both strategically and on the spot.
Strong command of civil/administrative law; Japan competition law understanding and international commercial law. Previous experience in identifying and resolving legal and compliance issues quickly and effectively and ability to make on the spot risk calls. Previous experience prioritizing conflicting demands from multiple business clients in an extremely fast paced environment. Strong personal integrity and commitment to operating ethically and professionally. Strong interpersonal skills and demonstrated team player ability
Preferred Qualifications / Skills:
Demonstrated experience providing legal advice and negotiating contracts in a highly regulated environment Team Player essential Commercial customer orientation imperative. Ability to work independently Strong financial acumen. Adaptable/Flexible: Being open to change in response to new information, different or unexpected circumstances, and/or to work in ambiguous situations Clear thinking: Simplifying strategy into specific actions with clear accountability, making decisions with speed and accuracy based on best available information, and communicating priorities clearly and concisely Strong project management, prioritization and critical thinking skills. Lean mindset, solution oriented.
External focus: Understanding areas of law, regulations, risks, marketplace dynamics, industry trends, and the compliance landscape.
Relocation Assistance Provided: No